Efficiency and safety of omalizumab in patients diagnosed with severe asthma using it for over 10 years

Omalizumab, used in the treatment of severe allergic asthma, is a monoclonal antibody that has been shown to be effective and its usage is increasingly widespread. This study aimed to investigate the effectiveness and safety of omalizumab in patients with severe allergic asthma who have been treated with it for 10 years or more. Material and Methods The effectiveness and safety of omalizumab treatment were evaluated by retrospectively examining patients' files. Clinical evaluation of patients during omalizumab treatment was performed monthly. The level of asthma symptom control was used for the assessment of treatment effectiveness as specified in the Global Initiative for Asthma (GINA) guidelines. Additionally, current treatments, hospital admissions, attack frequencies, and side effects were recorded. Results 36 patients were included in the study. Of these patients, 25 were female with a mean age of 54.7±12.9 years. The total IgE level was 247.1±179.4 IU/ml, and the eosinophil level was 419.5 ± 240.9 /µL. The duration of omalizumab treatment was 11.3±0.9 years (range: 10-15 years). At the end of omalizumab treatment, 23 (63.9%) patients had well controlled asthma, while 13 (36.1%) had not well controlled asthma. When evaluating the past year, 16 (44.4%) patients had no unplanned doctor visits, while 5 patients had one and 4 patients had two hospital admissions due to asthma exacerbation. Systemic steroid use was present in 11 patients within the past year. Although there was no statistical difference in disease control over the years, it was observed that disease control was particularly worse after 6 years compared to the initial years. Additionally, when the correlation between initial IgE and eosinophil levels and long-term controls was analyzed, there was no relationship observed with IgE levels, while better control was observed in patients with eosinophil levels above 500/µL. Patients did not experience any significant adverse effects associated with omalizumab. Throughout the entire treatment period, 4 patients experienced local side effects, and 3 patients experienced myalgia believed to be related to the drug. These side effects were observed within the first three years after starting treatment, with no side effects observed after the third year of treatment. Conclusion This is the first study encountered in the literature evaluating patients using omalizumab for 10 years or more. This study demonstrated that under real-life conditions, omalizumab treatment lasting for 10 years or more is an effective and well-tolerated treatment for uncontrolled allergic asthma.